Description

Company Description

Insmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most valuable resource is our employees, and everything we do is motivated by a patients-first mentality. We are dedicated to growing our team with talented individuals from around the world who are willing to challenge the status quo, solve problems, and work collaboratively with a sense of urgency and compassion.

Guided by our core values of collaboration, accountability, passion, respect, and integrity, we aim to foster an inclusive, diverse, and flexible work environment, where our employees are recognized for leaning in and rolling up their sleeves. If you share our vision and want to work with the most dedicated people in the biopharma industry, come to Insmed to accelerate your career.

Recognitions

Consistently Ranked Science 's Top Employer

Insmed is dedicated to creating a collaborative environment where our team can thrive. Every day, our employees turn their passion for science and research into innovative solutions for patients. That's why we've been named the No. 1 company to work for in the biopharma industry in Science 's Top Employers survey for four years in a row.

A Certified Great Place to Work®

We believe our company is truly special, and our employees agree. In July 2025, we became Great Place to Work-certified in the U.S. for the fifth year in a row. We are also honored to have been listed on the Best Workplaces in Biopharma™, Best Workplaces in New York™, PEOPLE® Companies That Care, Best Workplaces for Women™, Best Workplaces for Millennials™, and Best Medium Workplaces™ lists.

Overview

The Associate Director, Quality Control will be responsible for leading and overseeing all Quality Control activities related to inhalation products, including both Active Pharmaceutical Ingredients (API) and Drug Product. This role will manage external QC laboratories to ensure the timely and compliant execution of release, stability, and in-process testing in accordance with cGMP, regulatory requirements, and company quality standards. The successful candidate will provide strategic and technical oversight for laboratory operations, including routine testing, data review, investigations, and documentation. The individual will work collaboratively with cross-functional teams to ensure seamless execution of QC deliverables in support of clinical and commercial programs. A key aspect of this role involves managing contract testing organizations (CTOs) to ensure performance, compliance, and timely execution of testing activities. Core responsibilities include maintaining regulatory compliance, ensuring data integrity, and driving operational excellence within QC functions. A deep understanding of GMP, quality control processes, and analytical testing for inhalation products is essential, along with proven leadership experience in a dynamic, regulated environment.

Responsibilities

• Provide oversight and technical direction for all Quality Control activities conducted at external laboratories (CTOs and contract partners) related to inhalation products, including API and Drug Product testing for release, stability, and in-process control.
• Ensure external labs operate in full compliance with cGMP, regulatory expectations, and Insmed quality standards. Support inspection readiness and provide QC-related documentation and responses during regulatory inspections and audits.

• Position Requirements (Required and/or Preferred Skills, Experience and Education):
• Bachelor's degree in chemistry, Biochemistry, or related discipline with 10+ years of experience, or MS with 8+ years of experience or PhD with 5+ years of experience in the pharmaceutical industry, specifically Quality control department with at least 5 years in Quality Control roles involving oversight of external testing laboratories.
• Hands-on expertise in analytical lab testing for inhalation dosage forms and other small molecule dosage forms. Experience with inhalation and combination products is preferred.
• Proficient in regulatory requirements, including cGxP, CMC, ICH, and compendial standards (USP/EP/JP).
• Excellent analytical and problem-solving skills, particularly in the context of technical troubleshooting and investigation management.
• Effective communication skills, both verbal and written, including experience drafting regulatory responses and QC sections of submissions.
• Strong organizational and project management skills, with a focus on timeliness, quality, and compliance.
• Must embody the core values of Collaboration, Accountability, Passion, Respect, and Integrity, and demonstrate the ability to work in a diverse, dynamic environment. Individuals must demonstrate the ability to interact successfully in a dynamic and culturally diverse workplace.
• Review and approve analytical method execution, instrument qualification records, and data packages generated by external labs, with small molecule projects and particular focus on inhalation-specific testing (e.g., APSD, MMAD, delivered dose, particle size distribution).
• Lead and approve deviation investigations, OOS, and OOT results generated by external labs. Ensure thorough root cause analysis and appropriate CAPA implementation.
• Ensure external laboratory documentation—including CoAs, test methods, protocols, and reports—meets Insmed's data integrity standards and regulatory requirements. Review and approve external lab records as part of batch disposition process.
• Review and support the development of product specifications and justification documents across the lifecycle of inhalation products. Ensure alignment with regulatory guidance and clinical/commercial phase requirements.
• Contribute QC content for regulatory filings (IND, NDA, BLA), and collaborate with Regulatory Affairs to prepare high-quality responses to agency queries involving QC data or practices from external labs.
• Collaborate with Analytical Development, Quality Assurance, Regulatory Affairs, Supply Chain, and other departments to ensure external QC activities align with project timelines and product lifecycle needs.
• Establish quality and delivery KPIs for contract labs. Routinely assess performance, resolve issues, and ensure timely completion of all QC testing and reporting deliverables.
• Manage multiple external QC workstreams across development and commercial programs under tight timelines. Proactively identify risks, escalate concerns, and drive resolutions efficiently.
• Ensure all analytical activities comply with cGxP, ICH guidelines, and regulatory standards for the pharmaceutical industry, including USP/EP/JP requirements.
• Interpret complex data to solve challenging problems and provide scientific direction within the AR&D laboratory.

Travel:

• This position requires up to 10% travel

Salary Range

$139,000 - $195,200 a year

Compensation & Benefits

At Insmed, we're committed to investing in every team member's total well-being, now and in the future. Our benefit programs vary by country but we offer the following to all Insmed team members, regardless of geographic location:

• Flexible approach to how we work
• Health benefits and time-off plans
• Competitive compensation package, including bonus
• Equity Awards (Long-Term Incentives)
• Employee Stock Purchase Plan (ESPP)

For more information on U.S. benefits click here.

Additional Information

Insmed Incorporated is an Equal Opportunity employer. We do not discriminate in hiring on the basis of physical or mental disability, protected veteran status, or any other characteristic protected by federal, state, or local law. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.

Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source. Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement.

Insmed is committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, its services, programs, and activities. To request reasonable accommodation to participate in the job application or interview process, please contact us by email at [email protected] and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.

Applications are accepted for 5 calendar days from the date posted or until the position is filled.